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Question clinique
Is linagliptin (Tradjenta) non inferior to glimepiride in adults with poorly controlled type 2 diabetes?
L’Essentiel
This study found that linagliptin is non inferior to glimepiride for reducing the risk of cardiovascular death, myocardial infarction and stroke in adults with type 2 diabetes at an increased risk of cardiovascular disease. Although hypoglycemic events occurred significantly more often in patients treated with glimepiride, study targeted levels of HA1c (mean 7.2%) were consistent with levels previously shown to unnecessarily increase the risk of severe hypoglycemia and premature mortality. The Good Rx price (accessed 9/19/19) for a one month supply of linagliptin in the USA is $378 USD vs $3 USD for glimepiride. In Canada, based on the Ontario Drug Benefit/Formulary/Comparative Drug Index, comparative costs for a one month supply of linagliptin is $80 CAD vs $15 CAD for glimepiride. 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry
Cadre: Outpatient (primary care)
Sommaire
Clinicians have many options for second-line treatment to metformin monotherapy in adults with poorly controlled type 2 diabetes. These investigators identified adults with type 2 diabetes, glycated hemoglobin (HA1c) of 6.5% to 8.5%, and high cardiovascular risk (e.g. established CVD disease, multiple risk factors including hypertension, smoking, hyperlipidemia, age greater than 69 years, or evidence of microvascular complications). Eligible patients randomly received (concealed allocation assignment) linagliptin (5 mg/d) or glimepiride (1 to 4 mg/d, titrated to achieve target HA1c less than 7.5). Additional medications were added as needed for persistent hyperglycemia. Individuals masked to treatment group assignment assessed all outcomes. Complete follow-up occurred for 96% of participants for a mean of 6.3 years. Using intention-to-treat analysis, no significant difference occurred between the groups treated with linagliptin vs glimepiride in the primary end point of cardiovascular death, myocardial infarction, or stroke (11.8% vs 12.0%, respectively). There was also no significant difference between the two groups in all-cause mortality or study drop-out rates due to adverse events. Weight gain was significantly higher in the glimepiride group (3.4 pounds/1.54 kg). Rates of hypoglycemia including severe events were also increased in the glimepiride group (NNH of 3-4 for at least 1 episode).
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC